The quality management system is established within the organization and is necessary to achieve the quality objectives
The quality management model is a strategic decision of the organization. It combines the resources and process, the process management method of system management, according to the characteristics of the enterprise selected a number of system elements to be combined, generally including management activities, resource supply, product realization and measurement, analysis and improvement activities related to the process, It is understood that it covers the requirements of planning, implementing, monitoring, correcting and improving activities to determine the customer's needs, design, production, inspection, sales and delivery. It is generally documented to become the internal quality management of the organization. Claim.
In line with the requirements of the quality management system, the Quality Assurance and Quality Assurance Technical Committee of the International Organization for Standardization has developed the ISO9000 family of standards for organizations of different types, products, sizes and properties, which are defined by a number of interrelated or complementary Standard composition, which is well known for the ISO9001 "quality management system requirements", it is the request of the product requirements of the supplement, after several revision. On the basis of this standard, different industries have developed the corresponding technical specifications, such as ISO / TS 16949 "auto parts and maintenance of zero
Quality management system
Quality management system
ISO 9485 "Requirements for regulatory requirements for medical device quality management systems" and so on.
The ISO9001: 2008 standard is one of the quality management series developed by the ISO (International Organization for Standardization) / TC176 / SC2 Quality Management Subcommittee on Quality Management and Quality Assurance Technology Committee.